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. 2022 Nov 24;10:1062736. doi: 10.3389/fpubh.2022.1062736

Table 1.

Research variables.

Categories Variables Specific indicators Definition
Basic information Indication / /
Tumor type
Marketing time
Medical insurance access time
Trial design characteristics Primary endpoint Only OS Only taking one of OS, PFS and ORR as primary endpoint
Only PFS
Only ORR
Other Not taking any of the endpoints of OS, PFS, ORR as primary endpoint
Two endpoints Two endpoints in OS, PFS, and ORR are used simultaneously as primary endpoints
Phase Phase I Phase of the pivotal clinical trials included in this study
Phase II
Phase III
Blinded trial Yes/No Whether the pivotal clinical trials included in the study were blinded
Control group Yes/No Whether the pivotal clinical trials included in the study had a control group
Randomization Yes/No Whether the pivotal clinical trials included in the study were randomized
Clinical outcomes Risk benefit HROS data available (Yes/No) Whether HROS, HRPFS data of the drug are provided
HRPFS data available(Yes/No)
Risk benefit in OS (Yes/No) “Benefit” means an HR of < 1. “No benefit” refers to HR ≥ 1 or P ≥ 0.05 Risk benefit = (1-HR)100%
Risk benefit in PFS (Yes/No)
Magnitude of RiskOS benefit Comparing HR values for drugs with risk-benefit, the smaller the HR, the greater the risk of disease progression or death reduced by the drug, and the greater the risk benefit.
Magnitude of RiskPFS benefit
Survival benefit Survival benefit for mOS The difference in median survival time between the experimental and control groups
Survival benefit for mPFS
Reimbursement decisions Positive /negative Whether the drug indications are included in the NRDL (2021 edition)